Cleared Traditional

K832905 - QUALITATIVE ENZYME IMMUNOASSAY-DETECT

K832905 is the FDA 510(k) clearance for QUALITATIVE ENZYME IMMUNOASSAY-DETECT by Btc Diagnostics, Inc.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K832905 · Btc Diagnostics, Inc. · Chemistry device
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Feb 1984
Decision
158d
Days
Class 2
Risk

K832905 is an FDA 510(k) clearance for the QUALITATIVE ENZYME IMMUNOASSAY-DETECT. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Btc Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on February 3, 1984 after a review of 158 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Btc Diagnostics, Inc. devices

Submission Details

510(k) Number K832905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1983
Decision Date February 03, 1984
Days to Decision 158 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 88d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 116
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K832905.
ANSWER ONE-DAY
K843238 · Armkel, LLC · Sep 1984
BETA STICK, PREGNANCY TEST
K841415 · Quidel Corp. · Jul 1984
ACCURATE BETA 30 PREGNANCY TEST KIT
K841602 · Organon, Inc. · May 1984
EARLY PREGNANCY DETECTION TEST KIT
K833466 · Quidel Corp. · Nov 1983
HOME PREGNANCY TEST KIT HPK #1
K831051 · Quidel Corp. · May 1983
HOME PREGNANCY TEST KIT
K831108 · Quidel Corp. · May 1983